NCT07563049进行中（未招募）4 期
Evaluation Of Carboxytherapy As An Adjuvant To Narrowband-Ultraviolet B Phototherapy For The Treatment Of Stable Non-Segmental Vitiligo: A Clinical And Biochemical Study .
Kasr El Aini Hospital1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2024年9月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Vitiligo Extent Score for a Target Area (VESTA)
研究概览
简要总结
Patients with stable vitiligo with 2 or more symmetric patches, 2 on acral sites and/or 2 on non acral sites will be recruited and assessed for eligibility for inclusion to receive NB-UVB on the whole body, and carboxytherapy on one randomized side.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with stable non-segmental vitiligo (≥2 symmetrical patches of diameter less than 2 cm on acral or ≥ 2 symmetrical patches on non-acral sites). Subjects were stable for twelve or more months.
排除标准
- •Subjects with unstable vitiligo.
- •Subjects with segmental vitiligo.
- •Pregnant females.
- •Severe anemia (Hb <7 gm/dl).
- •Cardiac/hepatic/renal/respiratory failure.
- •Superficial thrombophlebitis.
- •Subjects with history of skin malignancy or precancerous conditions like Xeroderma pigmentosum.
- •Subjects with other autoimmune disorders.
- •Systemic drugs for vitiligo in the last 3 months.
研究组 & 干预措施
NB-UVB combined with carboxy
Active Comparator
干预措施: NB-UVB combined with carboxy (Device)
NB-UVB
Placebo Comparator
干预措施: NB-UVB alone (Device)
结局指标
主要结局
Vitiligo Extent Score for a Target Area (VESTA)
时间窗: 6 months- 1 year
Assessment of the treatment response in a target area Range 0-100%
Estimation of human E-Cadherin using ELISA
时间窗: 6 months -1 year
Estimation of malondialdehyde by spectrophotometer
时间窗: 6 months-1 year
次要结局
- Patients' global satisfaction(6 months -1 year)
研究者
Rana F Hilal, MD
Assistant Professor
Kasr El Aini Hospital
研究点 (1)
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